- National Institutes of Health (NIH)
- Standardized Collection of Standardized Clinical Data
- Collection of Participant-Provided Information
- Linking of Clinical and Other Data for Research
- Use of Clinical Data for Research
STATUS: Closed Project
The ADAPTABLE (Aspirin Dosing: A Patient centric Trial Assessing Benefits and Long Term Effectiveness) trial was the first major randomized comparative effectiveness trial to be conducted by the National Patient Clinical Research Network (PCORnet). This pragmatic clinical trial compared the efficacy and safety of two different daily doses of aspirin widely used for patients with chronic cardiovascular disease. The ADAPTABLE trial encompassed several key features, including enrollment of 20,000 patients across six large health care systems; an internet portal to consent patients and collect patient reported information regarding risk factors, medications, and experiences; and reliance on existing electronic health record (EHR) data sources for baseline characteristics and outcomes follow up.
PROJECT PURPOSE & GOALS
Given that ADAPTABLE relied on patients to report key information at baseline and throughout follow up, it represented a unique opportunity to develop, pilot, and evaluate methods to validate and integrate patient reported information with data obtained from the EHR. The project generated tools and data standards that could be deployed in other patient-centered outcomes research (PCOR) studies beyond the ADAPTABLE trial.
Develop, test, and validate meta-data standards for patient-reported information to streamline data capture and to describe the completeness, consistency, and fitness-for-use of patient-reported data in EHR research.
Evaluate the validity of patient reported data through systemic comparison with EHR data. The project will develop a Patient-Reported Data Assessment Tool to quickly and efficiently evaluate concordance of patient-reported data and EHR data.
Develop approaches to resolve inconsistencies between patient-reported data and EHR-derived data.
Facilitate enrollment in study-specific target populations within larger health systems.
PROJECT ACHIEVEMENTS & HIGHLIGHTS
The team compiled a literature review on data and metadata standards for patient-reported data in EHR-based trials to inform the development of a priority list of metadata standards. The report included recommendations on how to merge patient-reported and EHR data, proposed an evaluation to investigate building knowledge around data standards, and provided guidance to inform future patient-reported data use for research.
The team developed a Patient-Reported Data Assessment tool on the PopMedNet™ to enable comparing patient-reported data and EHR information using a menu-driven query tool. When tested, the tool was found to support the conduct of pragmatic clinical trials. A technical report and use documentation were developed to support using tool.
The team identified 68 patient-reported data elements for submission to LOINC, and published these on the PCORnet website. The data elements were included in a REDCap shared library to support implementation of 50 patient-reported data elements in future studies. The patient-reported data elements were included in the June 2018 release of LOINC.
The team published a joint white paper on available resources for best practices, key challenges, information gaps, and future research needs in the use of patient-reported health data in pragmatic studies. The team has also completed a report highlighting recommended approaches to resolving inconsistences between patient-reported and EHR.
PUBLICATIONS, PRESENTATIONS, AND OTHER PUBLICALLY AVAILABLE RESOURCES
The project team co-authored a summary report of the 2017 ADAPTABLE Supplement Roundtable Meeting. The report is available here:https://dcricollab.dcri.duke.edu/sites/NIHKR/KR/ADAPTABLE%20ROUNDTABLE%20SUMMARY_1_22.pdf
The literature review of data and metadata standards for patient-reported data in EHR-based trials includes descriptions of the metadata standards, and a dictionary describing each element. The report is available here: http://rethinkingclinicaltrials.org/news/july-23-2018-new-report-summarizes-patient-reported-health-data-and-metadata-standards-from-the-adaptable-trial/
- The team produced a Patient Data Assessment Tool using PopMedNet that allows investigators to compare patient-reported health data and EHR information using a menu-driven query tool, and is available on GitHub here: https://github.com/PopMedNet-Team/ADAPTABLE
- The user documentation for the Patient Data Assessment Tool is published here: https://dcricollab.dcri.duke.edu/sites/NIHKR/KR/ADAPTABLE%20Supplement%20MDQ%20Documentation_v1.0.pdf.
- A report summarizing the development of the menu-driven query tool is available here: https://dcricollab.dcri.duke.edu/sites/NIHKR/KR/ADAPTABLE%20Supplement%20MDQ%20Testing%20Summary_v1.0.pdf
- The addition of 50 ADAPTABLE patient-reported data elements were included in the June 2018 release of LOINC and can be found here: https://r.details.loinc.org/LOINC/89070-7.html
- LOINC Patient-Reported Data Elements were published in the NIH/NLM CDE repository and REDCap shared library to support implementation of 50 patient‑reported data elements in future studies and can be found here: https://cde.nlm.nih.gov/cde/search?selectedOrg=External%20Forms&classification=ADAPTABLE
A consensus statement emerging from the 2017 ADAPTABLE Supplement Roundtable Meeting was published in the Journal of American Medical Informatics Association in February 2020. https://pubmed.ncbi.nlm.nih.gov/32027359/
A report on key considerations for collecting patient-reported health information in pragmatic clinical trials that emerged from the 2017 ADAPTABLE Supplement Roundtable Meeting was published in Healthcare in September 2020. https://pubmed.ncbi.nlm.nih.gov/32919581/
Below is a list of ASPE-funded PCORTF projects that are related to this project
Conceptualizing a Data Infrastructure for the Capture and Use of Patient Generated Health Data (PGHD) – This Office of the National Coordinator for Health (ONC) project was a multi-pronged effort to combine PGHD data with medical record data across multiple health information systems and devices. This began with an assessment of the necessary data collection tools, technical barriers, data donation policies, and regulatory gaps. It then demonstrated successful capture and use of PGHD in two pilot sites. One site focused on app-driven capture of PGHD and its integration into physician workflow to achieve better care coordination and population management for diabetes patients. The other site tested a technical platform capturing PGHD to support care for orthopedic surgery, behavioral health, bariatric surgery, and stroke.
Advancing the Collection and Use of Patient-Reported Outcomes (PROs) through Health Information Technology (IT) - This is a cross-agency project between Agency for Healthcare Research and Quality (AHRQ) and ONC. This project aimed to standardize the integration of PRO data in EHRs and other health IT solutions to support the sharing of this information. This standardized integration and the resulting consistency across products was achieved by using data element and data capture standards.